MAUDE Adverse Event Report: XTANT MEDICAL SPIDER CERVICAL PLATING SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	N60000160
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned complaint system screwdriver showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The hex tip was fractured as reported, and the distal end was worn and rounded with the tin coating wearing from the instrument.A functionality assessment was not performed due to the damaged condition of the instrument, which was removed from distributable inventory.It was reported that during the drilling process to prepare the patient bone, the physician noted that the patient's bone was extremely dense.Patients with unusually dense bone may require drilling and tapping to prepare the surgical site for screw placement.Dense bone may also require the user to apply increased rotational force to the screwdriver, which may result in the identified instrument malfunction.The complaint investigation suggests that excessive rotational force due to extremely dense patient bone may have contributed to the instrument malfunction.
Event or Problem Description
The company received notification on 9/02/2021 of a system screwdriver that had the distal tip fracture during a surgical procedure when tightening a system screw.The fractured portion of the screwdriver was removed from the surgical site, and the procedure was successfully completed with an alternate available instrument.There were no known patient complications associated with this complaint.The complaint instrument arrived at the manufacturer for assessment on 9/07/2021.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 12558277
• Report Number: 3005031160-2021-00020
• Device Sequence Number: 983179
• Product Code: KWQ
• UDI-Device Identifier: M697N600001601
• UDI-Public: M697N600001601
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N60000160
• Device Lot Number: 739601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other